Vitamin D in Systemic Sclerosis Patients With Periodontitis

NCT04066842 | Completed DMC

• 1 other identifier: 10-918
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Vitamin D levels

  Evaluation of serum Vitamin D levels

  1 year

Study Arms (4)

1 - Controls

Control Healthy controls

Other: Observation

2 - SSc

SSc Systemic Sclerosis

Other: Observation

3 - Cardiovascular

Cardiovascular Cardiovascular disease

Other: Observation

4 - SSc+Periodontitis

SSc+ Periodontitis Systemic Sclerosis with Periodontitis

Other: Observation

Interventions

Observation OTHER

Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease

1 - Controls; 2 - SSc; 3 - Cardiovascular; 4 - SSc+Periodontitis

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study

You may qualify if:

• Presence of at least twenty teeth
• CP with a minimum of 40% of sites with a clinical attachment level (CAL)
• ≥2mm and probing depth (PD) ≥4mm;
• Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
• Presence of ≥40% sites with bleeding on probing (BOP)

You may not qualify if:

• Intake of contraceptives
• Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
• Status of pregnancy or lactation
• Previous history of excessive drinking
• Allergy to local anaesthetic
• Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Sponsors & Collaborators

• University of Messina: lead

Study Sites (1)

University of Messina

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Observation

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Assistant Professor

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: November 1, 2015
• Primary Completion: May 15, 2019
• Study Completion: May 30, 2019
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Public register
• Access Criteria: Policlinic Messina website

Locations

IT (1)